510(k) · Cleared

Cleared

Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage Troponin-I

K973126510(k) TraditionalCleared Oct 6, 199747-day reviewClass II21 CFR 862.1215

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biosite Incorporated · JHX Fluorometric Method, Cpk Or Isoenzymes

Cleared on Oct 6, 1997 after a 47-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 11 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it.

Decided: Oct 6, 1997
Review: 47 days
Class: Class II
Product code: JHX
Recalls: None
Predicates: 0

10 later devices descend from it, 5 citing it directly. 2 of the 11 devices in this family, counting this one, have a Class I recall.

This deviceK973126 Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage…Biosite Incorporated · 1997
Descendant · cites it directly · 3 of its ownK030286 Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 2003 · Recalled (Class I)
Descendant · 2 generations on · 2 of its ownK093758 BGM Galectin -3Bg Medicine, Inc. · 2010
Descendant · cites it directly · 2 of its ownK040437 Triage Profiler S.O.B. PanelBiosite Incorporated · 2004
Descendant · 3 generations on · 0 of its ownK140436 ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS…Fujirebio Diagnostics,Inc. · 2014
Descendant · 3 generations on · 0 of its ownK111452 Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag · 2011 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2001high 5 (2004) · low 0 (2002)2026

Class I recalls in this family

K030286 Triage Cardio Profiler/Triage Cardiac Panelcites it directly · 2003
K042890 Triage D-Dimer Test, Model 981002 generations on · 2004

Most influential descendants

Showing 5 of 10 · See all

K030286Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 2003 · cites it directly3descendants
K093758BGM Galectin -3Bg Medicine, Inc. · 2010 · 2 generations on2descendants
K040437Triage Profiler S.O.B. PanelBiosite Incorporated · 2004 · cites it directly2descendants
K140436ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3…Fujirebio Diagnostics,Inc. · 2014 · 3 generations on0descendants
K111452Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag · 2011 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K973126	Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin…	Biosite Incorporated	1997	—
+1	K030286	Triage Cardio Profiler/Triage Cardiac Panel	Biosite Incorporated	2003	Class I
+2	K093758	BGM Galectin -3	Bg Medicine, Inc.	2010	—
+1	K040437	Triage Profiler S.O.B. Panel	Biosite Incorporated	2004	—
+3	K140436	ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT…	Fujirebio Diagnostics,Inc.	2014	—
+3	K111452	Presage ST2 Assay	Critical Care Diagnostics, Inc. (Dba Critical Diag	2011	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	1
2004	5	1
2010	1	0
2011	1	0
2014	1	0

FIG. 1 — Lineage of K973126, 1997–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JHX device

#1 K234005 Access CK-MBscore 7.2 · 2 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (10)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030286	Triage Cardio Profiler/Triage Cardiac Panel Class I	Biosite Incorporated	2003	3
K040437	Triage Profiler S.O.B. Panel	Biosite Incorporated	2004	2
K033747	Ramp CK-MB Assay	Response Biomedical Corp.	2004	0
K033745	Ramp Troponin I Assay	Response Biomedical Corp.	2004	0
K012040	Ramp Myoglobin Assay	Response Biomedical Corp.	2001	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K030286Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 2003 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 12 Class I recalls
K042890Triage D-Dimer Test, Model 98100Biosite Incorporated · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K030286 (Biosite Incorporated, 2003) has gone furthest, with 3 descendants of its own.

How does its category compare?

All JHX devices

JHX Fluorometric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JHX

1in 2024

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JHX

Too few JHX 510(k)s in any year since 2007 to give a median.

Recalls per year · JHX

2in 2015

2007high 4 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JHX

1in 2025

2007high 40 (2009) · low 1 (2025)2025

MAUDE reports naming product code JHX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	2
2008	0	—	1	6
2009	1	—	1	40
2010	0	—	0	27
2011	0	—	0	4
2012	1	—	4	18
2013	0	—	0	8
2014	0	—	0	17
2015	0	—	2	8
2016	0	—	0	10
2017	1	—	0	3
2018	0	—	0	16
2019	0	—	0	7
2020	0	—	0	3
2021	0	—	0	10
2022	1	—	0	2
2023	0	—	0	2
2024	1	—	0	2
2025	0	—	0	1
2026	0	—	0	—

What is it indicated for?

For the quantitative measurement of CK-MB, Myoglobin and Troponin-I in heparinized whole blood. To be used as an aid in the diagnosis of myocardial infarction.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973126 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973126: Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage Troponin-I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973126

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026